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Recall Observatory FDA recall evidence

Device product

EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

Z-2749-2018

June 04, 2018

Class III

Product summary

Firm
Richard-Allan Scientific Company
Event
Event 80584
Status
Terminated
Classification
Class III
Quantity
1,039 cases/40 boxes per case
Official record key
device-enforcement:Z-2749-2018

Official wording

Reason: Mislabeled product

Code information: Lot # 17269A0

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeled